FDA Pushes Back Review of BMS Lymphoma Treatment

The FDA pushed back its decision date by three months for Bristol Myers Squibb’s lisocabtagene maraleucel (liso-cell) for relapsed or refractory large B-cell lymphoma.

The FDA accepted the Biologics License Application (BLA) for the drug in February for priority review, and the agency was originally expected to make a decision on the drug by Aug. 17.

But BMS submitted additional information and the agency deemed that a major amendment requiring more review time. The company now expects a decision on the drug by Nov. 16.